A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)

Completed · Phase 1 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).

Key facts

Study ID

NCT02807675

Run by

Acorda Therapeutics

People needed

36

Starts

2016-06-01

Expected to finish

2016-11-01

Last updated by the study team

2017-01-30

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years
• diagnosis of Parkinson's disease and motor fluctuations and early morning OFF symptoms
• classified as Stage 1 to 3 on the modified Hoehn and Yahr scale for staging of PD severity (in an ON state)
• subjects who are on a l-dopa-containing therapy, not including Rytary (or equivalent), must be stable on oral l-dopa-containing therapy for at least 2 weeks prior to the Screening Visit with a l-dopa/decarboxylase inhibitor (DDI)-containing regimen
• subjects who are on a l-dopa-containing therapy, when including Rytary (or equivalent), should be on a stable dose for at least 6 weeks prior to the Screening Visit
• the frequency of l-dopa administrations must be at least 3 times during the waking day and a total daily l-dopa dose of ≤ 1600 mg.
• on a stable regimen of their standard PD medications
• on a stable regimen of any blood pressure reducing medications (if applicable) for at least 30 days prior to screening
• forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%
• no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, electrocardiogram, clinical laboratory test results
• negative drug and alcohol testing
• negative pregnancy test for all women.

You may not qualify if…

• participated in any prior study with CVT-301
• dyskinesia of a severity that would significantly interfere with the subject's ability to participate or perform study procedures (as determined by the UPDRS Part 4)
• any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver
• have a current history of symptomatic orthostatic hypotension or are treated with medications to treat orthostatic hypotension (for example droxidopa, fludrocortisone), if they have severe dysautonomia
• have chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last 5 years.

Where it is running

• Site #9015 — Fountain Valley, California, United States
• Site #9002 — Boca Raton, Florida, United States
• Site #9017 — Hallandale, Florida, United States
• Site #9008 — St. Petersburg, Florida, United States
• Site #9018 — Sunrise, Florida, United States
• Site #9004 — Tampa, Florida, United States
• Site #9016 — Atlanta, Georgia, United States
• Site #9009 — Chicago, Illinois, United States
• Site #9003 — Farmington Hills, Michigan, United States
• Site #9005 — West Bloomfield, Michigan, United States
• Site #9007 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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